Clinical and pharmacokinetic study of fractionated doses of oral etoposide in pediatric patients with advanced malignancies

Medical Science Monitor

Volumn 8, Issue 9, 2002, Pages

  Gregianin, Lauro J ^a   Brunetto, Algemir L ^a   Di Leone, Luciane ^a   Dalla Costa, Teresa ^a   Santos, Pedro P ^a   Schwartsmann, Gilberto ^a  

^a NONE   (Brazil)

Author keywords

Children; Oral etoposide; Phase I study

Indexed keywords

ETOPOSIDE;

ADOLESCENT; ADVANCED CANCER; ARTICLE; CHILD; CLINICAL ARTICLE; CLINICAL TRIAL; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG INDUCED DISEASE; DRUG TOLERABILITY; FEMALE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; LEUKOPENIA; MALE; MAXIMUM TOLERATED DOSE; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; TREATMENT OUTCOME;

ADMINISTRATION, ORAL; ADOLESCENT; ANTINEOPLASTIC AGENTS, PHYTOGENIC; AREA UNDER CURVE; CHILD; CHILD, PRESCHOOL; ETOPOSIDE; FEMALE; HUMANS; MALE; NEOPLASMS; TIME FACTORS; TREATMENT OUTCOME;

EID: 0036738595     PISSN: 12341010     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (31)

1. Lowis SP, Newell DR: Etoposide for the treatment of paediatric tumors: What is the best way to give it? Eur J Cancer, 1996; 32A: 2291-2297
2. Pommier Y, Fesen MR, Goldwasser F: Topoisomerase II inhibitors: The epidophyllotoxins, m-AMSA, and the ellipticine derivatives. In: Chabner BA and Longo DL: Cancer Chemotherapy and Biotherapy, second edition, Lippincott Raven Publishers, Philadelphia, 1996
3. Stewart DJ, Nundy D, Maroun JA et al: Bioavailability, pharmacokinetics and clinical effects of an oral preparation of etoposide. Cancer Treat Rep, 1985; 69: 269-273
4. Clark PI, Slevin ML, Joel SP: A pharmacokinetics hypothesis for the clinical efficacy of VP in SCLC. Proc Am Soc Clin Oncol, 1989; 8: 66
5. Slevin ML, Clark PI, Joel SP: A randomized trial to evaluate the effect of schedule on the activity of VP in small cell lung cancer. J Clin Oncol, 1989; 7: 1333-40
6. Splinter TAW, van der Gaast A, Kok TC: What is the optimal dose and duration of treatment with VP? I. Maximum tolerated duration of daily treatment with 50, 75, and 100 mg of oral VP. Semin Oncol, 1992; 19: 1-7
7. Johnson DH, Hainsworth JD, Hande KR, Greco FA: Combination chemotherapy with oral etoposide. Semin Oncol, 1992; 19: 19-24
8. Cavalli F, Sonntag RW, Jungi F et al: VP-16-213 monotherapy for remission induction of small cell lung cancer: a randomized trial using three dosing schedules. Cancer Treat Rep, 1978; 62: 473-475
9. Clark P, Cottier V, Joel S, Slevin M: Two prolonged schedules of single-agent oral etoposide of differing duration and dose in patients with untreated small cell lung carcinoma. Proc Am Soc Clin Oncol, 1991; 10: 268
10. Clark PI, Cottier B: The activity of 10-, 14-, and 21-day schedules of single-agent etoposide in previously untreated patients with extensive small cell lung cancer. Semin Oncol, 1992; 19: 36-39
11. Sonnichsen DS, Ribeiro RC, Luo X et al: Pharmacokinetics and pharmacodynamics of 21-day continuous oral etoposide in pediatrics patients with solid tumors. Clin Pharmacol Therapeutics, 1995; 58: 99-107
12. Needle MN, Molloy PT, Geyer JR et al: Phase II study of daily oral etoposide in children with recurrent brain tumors and other solid tumors. Med Pediatr Oncol, 1997; 29: 28-32
13. Sprinz E, Caldas AP, Mans DR et al: Fractionated doses of oral etoposide in the treatment of patients with Aids-related Kaposi sarcoma: A clinical and pharmacological study to improve therapeutic index. Am J Clin Oncol, 2001; 24: 177-84
14. Davidson A, Lewis I, Pearson ADJ et al: 21-day schedule oral etoposide in children - a feasibility study. Eur J Cancer, 1993; 29A: 2223-2225
15. Mathew P, Ribeiro RC, Sonnichsen D et al: Phase I study oral etoposide in children with refractory solid tumors. J Clin Oncol, 1994; 12: 1452-1457
16. Chamberlain MC: Recurrent brainstem gliomas treated with oral VP-16. J Neurooncol, 1993; 15: 133-139
17. Kushner BH, Kramer K, Cheung NKV: Oral etoposide for refractory or relapsed neuroblastoma. J Clin Oncol, 1999; 17: 3221-3225
18. Korones DN, Fisher PG, Cohen KJ, Dubowy RL: No responses to oral etoposide in 15 patients with recurrent brain tumors. Med Pediatr Oncol, 2000; 35: 80-82
19. Schwartsmann G, Caldas APF, Dalla Costa T et al: Phase I study of three-times daily oral etoposide in patients with refractory solid tumors. Clin Drug Invest, 2000; 19: 375-383
20. National Cancer Institute: Guidelines for reporting of adverse drug reactions. National Cancer Institute, Bethesda, MD, USA, 1988
21. WHO Handbook for reporting results of cancer treatment. Geneve, Switzerland: World Healt Organization Offset Publication No. 48; 1979
22. Schwartsmann G, Sprinz E, Kromfield M et al: Clinical and pharmacokinetic study of oral etoposide in patient with AIDS-related Kaposi's sarcoma with no prior exposure to cytotoxic therapy. J Clin Oncol, 1997; 15: 2118-2124
23. Gehan EA The determination of the number of patients required in a preliminary and follow-up trial of a new chemotherapeutic agent. J Chronic Dis, 1961; 13: 346-349
24. Strife RJ, Jardine I: Analysis of the anticancer drugs VP-16-213 and VM-26 and their metabolites by high performance liquid chromatography. J Chromatogr, 1980; 182: 211-220
25. Estlin EJ, Ablett S, Newell DR et al: Phase I trials in paediatric oncology - the European perspective. Invest New Drugs, 1996; 14: 23-32
26. Hainsworth JD: Extended-schedule oral etoposide in selected neoplasms and overview of administration and scheduling issues. Drugs, 1999; 58: 51-56
27. Arnold AM, Whitehouse JM: Etoposide: a new anti-cancer agent. Lancet, 1981; 2: 912-915
28. Slevin ML: The clinical pharmacology of etoposide. Cancer, 1991; 67: 319-329
29. Joel SP, Dolega-Ossowski E, Jones K et al: The bioavailability of oral VP during prolonged administration and development of a limited sampling strategy for the estimation of AUC after an oral dose. Proc Am Soc Clin Oncol Res, 1991; 32: 178
30. Hande KR, Krozely MG, Greco FA et al: Bioavailability of low-dose etoposide. J Clin Oncol, 1993; 11: 374-377
31. Schiavetti A, Varrasso G, Maurizi P et al: Ten-day schedule oral etoposide therapy in advanced childhood malignancies. J Ped Hematol Oncol, 2000; 22: 119-124